The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort - (CNS HAND)

This study has been completed.

Sponsor:

Holdsworth House Medical Practice

ClinicalTrials.gov Identifier:

NCT01434563

First Posted: September 15, 2011

Last Update Posted: October 24, 2012

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To determine the prevalence of HIV associated Neurological Disorder (HAND) in a population of HIV positive patients within a primary care setting compared with the HIV negative population. The investigators aim is to assess the use of optimal screening methods to assess HAND. For this the investigators will be comparing the performance of a group of persons who are HIV positive and a group of persons who are HIV negative to test their memory and concentration abilities over-time.

Subjects must have documented HIV, be english speaking, with life expectancy greater than 6 months, and must have adequate information available in their medical record to apply HAND predictive algorithm (HIV-associated neurological disease)

HIV negative

Must have documented negative HIV test within 12 months of study entry, have no traumatic brain injury or history of chronic neurological illness/psychiatric conditions (such as bipolar or depression),be english speaking and have no history of drug or alcohol abuse.

Eligibility

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Life time traumatic brain injury leading to loss of consciousness of at least 30 minutes.

Inability to comprehend or read English (as established by the English proficiency questionnaire).

Inability to attend the clinic for required study follow up visits.

History of chronic neurological illness.

Unstable psychiatric conditions such as bipolar disorder or depression.

Individuals with psychiatric disorder on the psychotic axis.

Active or past (within the last 6 months) severe alcohol or substance abuse sufficient, in the investigator's judgement, to prevent completion of tests or Inability to attend for the planned required study follow up visits.